MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-28 for FLOTRAC SENSOR WITH VAMP SYSTEM MHD6AZ5 manufactured by Edwards Lifesciences Dr.
[188744456]
One flotrac - vamp adult kit was returned for examination. The reported event of pressure measurement issue was not confirmed. Both the flotrac and dpt sensors of the flotrac unit zeroed and sensed pressure accurately on an ev1000 system. Pressure readings were also stable during 8 hours of output drift testing. Electrical testing showed that both input and output impedances were within specifications. Zero-offset also met specification. No leakage or occlusion was detected from kit during a pressure test. No visible damage was observed from the kit. Lot number was not provided, therefore review of the manufacturing records could not be completed. The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing. There was no evidence of a manufacturing nonconformance. No further actions will be taken at this time. Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks. The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor. Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated. A square-wave test may be performed by pulling the snap tab device and releasing quickly. Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system. Pressure readings should correlate with the patient? S clinical manifestations. It is not known if user or procedural factors may have contributed to the stated event. In this event, there was no patient compromise noted. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Patient Sequence No: 1, Text Type: N, H10
[188744457]
It was reported that the co was reading 20 and had a stroke volume of 180. The patient had an irregular a line waveform which was the cause of these abnormal numbers. There was no correlation between the blood pressure (bp) on the ev1000 and the bedside monitor. The bedside monitor was reading a bp of 150/40 and the ev1000 was reading a pressure of 110/40. The ev1000 was turned off and the bedside monitor was used for their bp. The nurse reconnected the transducer to the ev1000 on and it was the same issue. The transducer was replaced with a new pressure monitoring kit. The patient was not treated via any of the hemodynamic parameters and no patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10759 |
| MDR Report Key | 9770789 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS SAMANTHA EVELEIGH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOTRAC SENSOR WITH VAMP SYSTEM |
| Generic Name | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
| Product Code | DRS |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-21 |
| Model Number | MHD6AZ5 |
| Catalog Number | MHD6AZ5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |